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NCT Number: NCT06867484

Breast Re-irradiation After Second Ipsilateral Lumpectomy

The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer Cancer of the Breast ER+ Breast Cancer Estrogen-receptor-positive Breast Cancer HER2-negative Breast Cancer Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lynn Cancer Institute at Baptist Health, Inc., Boca Raton, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with ER+HER2- breast cancer
  • Provision of signed and dated ICF
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age ≥ 40 years
  • Oncotype < 26 (postmenopausal) <16 (premenopausal), Low, or Ultra-Low index.
  • Minimum interval of 18 months from last breast radiotherapy session.
  • Prior radiation therapy in the form of brachytherapy, external beam MV photons, protons or intraoperative radiation are allowed with an upper total dose limit of 68 Gy (EQD2) for those patients with prior records available.
  • Ipsilateral recurrence, unifocal < 3 cm with negative margins, N0, Tis and invasive (pathological staging)
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Planning target volume: whole breast (PTV: WB) ratio < 1/2
  • Life expectancy > 12 months
  • Individuals able to become pregnant: agreement to use highly effective contraception starting at screening through treatment, and for 1 year after the end of PBI. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately.

A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has not had menses at any time during the preceding 12 consecutive months)

Exclusion criteria

  • BRCA1/2 mutation or any other receptor subtypes
  • Individuals assigned male at birth with breast cancer
  • Pregnancy or breastfeeding
  • Skin involvement
  • Distant metastasis
  • Patients with initial high-risk triple negative or HER-2 enriched breast cancer will be excluded from the trial. However, if the initial subtype is not known, patients will still be allowed to enroll, and the initial primary tumor information will be recorded as missing on the clinical forms.
  • Other malignancies (except skin)
  • Connective tissue disorder (e.g., scleroderma, lupus)
  • Any other condition that may put a participant at higher risk, at the discretion of the investigator.

Treatment and study plan

Intensity Modulated Radiation Therapy (IMRT)

Radiation

40 Gy total in 15 consecutive weekday sessions to the partial breast

Primary outcomes

  1. Rate of grade 3 or higher treatment-related adverse events (AEs)

    Time frame: 1 year

    Adverse events will be collected using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) starting from the first radiation treatment. Grade 1 AEs are considered mild, grade 2 AEs are considered moderate, grade 3 AEs are considered severe, grade 4 AEs are considered life-threatening, and grade 5 AEs are considered fatal. The percentage of participants experiencing grade 3 or higher treatment-related AEs will be calculated.

Secondary outcomes

  1. Local recurrence-free survival (LRFS)

    Time frame: 5 years

    Local recurrence is defined as tumor recurrence in the reirradiated region. LRFS is defined as time from the start of radiation treatment to local recurrence or death, whichever occurs first, and will be estimated by Kaplan-Meier method. Participants who do not have local recurrence and are still alive will be censored to their final follow-up date.

  2. Overall survival (OS)

    Time frame: 5 years

    OS is defined as the time from the start of radiation treatment to death and will be estimated by Kaplan-Meier method. Participants who are still alive will be censored to their final follow-up date.

  3. Distant metastasis-free survival (DMFS)

    Time frame: 5 years

    Distant metastasis is defined as cancer spreading to other areas of the body. DMFS is defined as the time from the start of radiation treatment to time of distant metastasis or death and will be estimated by Kaplan-Meier method. Participants who do not have distant metastasis and are still alive will be censored to their final follow-up date.

  4. Mastectomy-free survival (MFS)

    Time frame: 5 years

    MFS is defined as the time from the start of radiation treatment to mastectomy or death, whichever occurs first, and will be estimated by Kaplan-Meier method. Participants who have not had a mastectomy and are still alive will be censored to their final follow-up date.

  5. Change in patient-rated cosmesis

    Time frame: Over 5 years

    Assessed using the National Surgical Adjuvant Breast and Bowel Project (NSABP) B39.0 questionnaire.

    Physical appearance. 22 questions, rated 1 (no difference between breasts) to 4 (large difference). Range 22-88 (worse).

    Recovery. 8 questions, rated 0 (not at all) to 10 (a lot). In 7 questions, higher is worse; scoring will be reversed for 1 item. Range 0-80 (worse).

    Feelings. 4 questions, rated 1 (all the time) to 5 (none of the time). Lower is better for 2 but worse for 2. Scoring for 2 items will be reversed. 4 questions related to pain rated from 0 (no pain) to 10 (worst pain). Range 0-40 (worse). One question is about pain treatment.

    Bothered. 27 questions, rated 0 (not at all) to 4 (very much). Range 0 -108 (worse).

    Satisfaction. Appearance of the treated breast rated from 1 (excellent) to 4 (poor). Satisfaction rated on a 5-item scale from totally satisfied to totally dissatisfied. Breast size before and after treatment: left larger, same, right larger.

Study contacts

Contact information is provided by the study sponsor or research team.

MCI Multisite Research Program

CONTACT

[email protected]

Youssef Zeidan, M.D., Ph.D.

CONTACT

[email protected]

(561) 955-5966

Sponsors and collaborators

Lead sponsor

Youssef Zeidan

Other

Collaborators

  • Boca Raton Regional Hospital

Registry information

Official study title

Breast Re-irradiation After Second Ipsilateral Lumpectomy (BRASIL Trial)

Acronym: BRASIL

Important dates

Study start
2025
Primary completion
2028
Study completion
2033
First posted
Mar 10, 2025
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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